The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 3.0 Diagnostic Ultrasound System.
Device ID | K123754 |
510k Number | K123754 |
Device Name: | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-12-06 |
Decision Date | 2012-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838067851 | K123754 | 000 |
00884838061439 | K123754 | 000 |
00884838061514 | K123754 | 000 |
00884838061521 | K123754 | 000 |
00884838061538 | K123754 | 000 |
00884838061569 | K123754 | 000 |
00884838061583 | K123754 | 000 |
00884838061620 | K123754 | 000 |
00884838061637 | K123754 | 000 |
00884838067806 | K123754 | 000 |
00884838067813 | K123754 | 000 |
00884838025295 | K123754 | 000 |